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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01163461
Other study ID # C6572-R
Secondary ID
Status Completed
Phase N/A
First received July 14, 2010
Last updated August 30, 2017
Start date September 1, 2010
Est. completion date September 30, 2014

Study information

Verified date August 2017
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a behavioral speech therapy trial for individuals who have suffered a stroke on the left side of the brain and have difficulty speaking. The name of this disorder is called 'aphasia'. Individuals who participate in this study will receive 60 hours of therapy for free (2 hours/day, 5 days/week, 6 weeks).


Description:

The study design was a single group (n=26) with repeated testing (3 times) pre- and post-treatment. All participants received the same treatment protocol (described in detail in Appendix A and in Minkina et al. (under review)). In order to control for improvement in language function related to passage of time, and for the effect of repeated exposure to outcome measures, individuals were randomly assigned to one of two conditions: delayed treatment or immediate treatment (Figure 2). Participants who were randomized to the delayed group received repeated testing three times before and three times after a six-week delay. During the delay phase they were permitted to participate in usual speech-language care (e.g., conversation groups and individual therapy).

Standardized assessments and outcome measures (described in detail below) were administered prior to the start of treatment (for both immediate and delayed groups), at the end of the delay phase (delayed group only), immediately after treatment termination, and at three months post-treatment.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date September 30, 2014
Est. primary completion date June 30, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- left hemisphere stroke

- monolingual English speaking

- right handed

- presence of aphasia

Exclusion Criteria:

- preexisting neurological condition

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
speech therapy
individuals will receive 60 hours of behavioral speech therapy

Locations

Country Name City State
United States VA Puget Sound Health Care System Seattle Division, Seattle, WA Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kendall DL, Hunting Pompon R, Brookshire CE, Minkina I, Bislick L. An analysis of aphasic naming errors as an indicator of improved linguistic processing following phonomotor treatment. Am J Speech Lang Pathol. 2013 May;22(2):S240-9. doi: 10.1044/1058-036 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Speech Production percent change in the number of untrained words spoken correctly Baseline to one week post treatment termination and three months post treatment termination
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